In order to confirm the feasibility of home monitoring with Monica AN 24, a licensed portable device for measuring fetal and maternal electrocardiogram (ECG), and the feasibility of inpatient monitoring with Monica AN 24 in patients with Propess (a vaginal licensed drug delivery system used for induction of labour), we will perform a pilot study that will include 20 women in each arm. Feasibility of monitoring with Monica AN 24 both in hospital and at home will be confirmed in a pilot study. The success will be defined as at least 10 minutes of continuous satisfactory trace in any given hour in at least 80% of the patient. A main study will then be conducted to assess the feasibility and acceptability of the Propess and Monica AN24package of care for women undergoing induction of labour. The research questions are: 1. Is outpatient induction with continuous monitoring technically feasible? 2. Does the Propess and Monica AN24 care package of care provide adequate clinical information in line with the UK National Institute of Clinical Evidence (NICE) Guideline for Induction of labour? 3. Is outpatient induction a concept that appeals to women? 4. What do women consider to be the advantages and disadvantages of this package of care? 5. What would women consider to be positive and/or negative outcome in future clinical trials of outpatient induction? 6. Do fetuses with abnormal electrocardiogram (ECG) patterns have evidence of subclinically impaired cardiac function (feasibility study)? 7. Do elevated concentrations of white blood cell components in the umbilical cord blood at birth influence fetal electrocardiogram (feasibility study)?
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Feasibility Defined as the Number of Eligible Women Who Are Successfully Monitored Remotely With Trans-abdominal Fetal Electrocardiogram (ECG) Monitoring Device (Monica AN24) While Undergoing Labour Induction.
Timeframe: 6 months